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Food Recalls Rise to Four a Day in Third Quarter, Reaching Highest Level of Activity in Eight Quarters, According to the ExpertRECALL Index

Drug and Medical Device Recalls also Increase; Consumer Product Recalls Decline

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INDIANAPOLIS, Nov. 15, 2012 /PRNewswire/ -- Food recalls occurred at an average rate of four a day in the third quarter of 2012 as documented by U.S. Food and Drug Administration (FDA) enforcement reports, according to the quarterly ExpertRECALL Index released today. This influx in recall activity affected nearly 8.5 million units of food and beverages, reflecting a 57 percent increase compared with the previous quarter.

The pharmaceutical and medical device industries also recorded sharp increases in recall activity, accounting for the most events recorded for each industry in more than two years. While the number of documented drug recalls more than doubled in the third quarter, they affected nearly 16.2 million units, or about a million fewer units when compared to the second quarter. The seventy percent increase in medical device recall activity also impacted fewer units than affected by recalls documented during the second quarter, dropping from 123.5 million units in the second quarter to 26.5 million in the third.

"The number of recalls we saw during the third quarter is troubling," said Mike Rozembajgier, vice president of recalls at Stericycle ExpertRECALL. "But as we enter the holiday season, it's even more worrisome to know that nearly one-quarter of food and beverage companies that faced a recall in the third quarter had more than one event. As consumers are bombarded with advertisements and messages from manufacturers and retailers during the holiday season, it will be much more difficult for companies to cut through the clutter and connect with consumers on recalls. This is why both of these groups need to do their part to ensure that the food served during holiday parties to family and friends is safe."

The ExpertRECALL Index also found that more than one-third of pharmaceutical companies named in third-quarter Enforcement Reports were affected by more than one recall. This is the highest percentage of repeat violations by pharmaceutical companies in at least the last nine quarters. Compounding pharmacies, which have recently made headlines in the news due to a recent deadly outbreak of fungal meningitis, saw a marked increase in recall activity with one specialty laboratory being involved in 81 recalls.

"Questions have been raised recently about whether compounding pharmacies are regulated enough to protect consumers," said Rozembajgier. "While I cannot speak to the reason for each recall, or for the FDA, state pharmacy boards or laboratories involved, the trend this data suggests is alarming because so many products meant to help patients are being discovered as potentially harmful or even deadly."

"We now have a window into the operations of one large-scale compounding  pharmacy, and the view is troubling, both in terms of the quantity and quality of compounded products in the commercial system," said Hogan Lovells Partner David M. Fox, who served as a senior FDA lawyer from 1994 to 2000. "We can now expect to see more recalls from commercial compounders in response to increased regulatory oversight and legal scrutiny."

While recalls of consumer products declined slightly, the number of affected units rose from 7.5 million in the second quarter to 12 million in the third quarter. Concerns related to structural collapses were the leading cause of recalls followed by laceration risks. Recalls of child nursery and equipment remained steady when compared with the second quarter, while recalls of toys slightly increased. The primary cause of children's and infant product recalls were risks that a child could fall out of the product.

The 2012 third quarter ExpertRECALL Index is the only report that aggregates and tracks cumulative recall data from the CPSC and the FDA. Stericycle ExpertRECALL compiles the ExpertRECALL Index from data issued by the U.S. Food and Drug Administration and the Consumer Product Safety Commission. The ExpertRECALL Index report is available online at http://www.expertrecall.com/recallindex.

About Stericycle ExpertRECALL™

Stericycle ExpertRECALL is the industry leader in managing consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. Stericycle ExpertRECALL streamlines the entire product recall process and manages Notification & Response, Processing & Tracking, and Compliance & Reporting for a variety of companies. For more information, visit http://www.expertrecall.com.

SOURCE Stericycle ExpertRECALL



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